study of isa247 (voclosporin) in de novo renal transplantation

Conditions: Kidney Diseases

Summary: this study will see if voclosporin is safe and effective in preventing kidney transplant rejection.

prograf® (tacrolimus) is associated with numerous side effects, including neurotoxicity, nephrotoxicity, polyoma nephropathy, qt prolongation, and new onset diabetes mellitus after transplant (nodat). voclosporin is a novel calcineurin inhibitor intended for use in the prevention of organ graft rejection. comparison(s): voclosporin at 3 dose levels (0.4, 0.6, and 0.8 mg/kg twice a day) compared to tacrolimus

Eligibility criteria:
inclusion criteria: * males and females aged 18 - 65 years inclusive at the time of screening. * patients must be receiving a first cadaveric or living donor renal transplant. * patients must be able to receive oral medication at time of randomization. * females who are not pregnant or nursing or planning to become pregnant during the course of the study, or 3 months after last dose of study medication. * sexually-active women of child-bearing potential (including those who are \< 1 year postmenopausal) and sexually-active men who are practicing a highly effective method of birth control. a highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly and will include implants, injectables, combined oral contraceptives, double-barrier method, sexual abstinence, or a sterile partner. sexually-active men and women of child-bearing potential should continue to practice contraception as outlined above during treatment and for ≥ 3 months after the last dose of voclosporin. * able to give written informed consent prior to screening procedures. * able to keep study appointments and cooperate with all study requirements, in the opinion of the investigator. exclusion criteria: * receiving a hla (human leukocyte antigen)identical living related transplant. * cold ischemic time \> 24 hours. * peak pra (panel reactive antibodies) \> 30% * cadaveric donors who are over age 60, non-heart beating donors, or any cadaveric donors positive for hiv, hepatitis b virus (hbv) or hepatitis c virus (hcv). * transplantation of multiple grafts (e.g. kidney and pancreas). * systemic infections requiring continued therapy at the time of entry into this study. (prophylaxis against cytomegalovirus \[cmv\] and/or pneumocystis carinii pneumonia (pcp) infection will be permitted). * serologic evidence or known latent human immunodeficiency virus (hiv), hepatitis b (hbv) or hepatitis c (hcv) virus. known negative serology prior to study entry may be used. * a current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation. * requires prohibited medications or treatment during the study. * alanine transaminase (alt), aspartate transaminase (ast), or gamma-glutamyl transferase (ggt) ≥ 3x upper limit of normal (uln) at time of transplantation. * white blood cell count ≤ 2.8 x 10\^9/l. * triglycerides ≥ 3x uln. * pregnant women or nursing mothers. * has used any investigational drug or device within 28 days or 5 half lives (whichever is longer) prior to enrollment. * previous exposure to voclosporin. * a history of active alcoholism or drug addiction within 1 year prior to study entry. * weighs \ 140 kg (308 lbs). * a history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, or that might cause the administration of voclosporin to pose a significant risk to the subject, in the opinion of the investigator. * allergy to iodine.

Keywords: randomized controlled trials immunosuppression adult kidney transplantation treatment outcome